Sr. R&D Engineer

Senior R&D Engineer

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; and Marton, New Zealand.

As Senior R&D Engineer, you will take full ownership of the technical execution for internal and contract product development projects. This is a high-impact role within the U.S. R&D organization, where you will be expected to champion innovation, navigate complex regulatory landscapes, and ensure the delivery of market-leading products through disciplined project leadership.

Responsibilities:

• Acting as a SME, champions complex product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products.
• Actively engage and collaborate on global cross functional product development teams.
• Medical Device Design Control and Risk Management: Leveraging a high level of experience and skill, independently draft/author all typical design control documentation in accordance with relevant internal SOPs such as: trace matrices, design verification plans and reports, risk documentation, design validation plans and reports, usability reports, final product labeling (including IFUs).
• Identify and lead interactions with external vendors such as test labs (e.g. biocompatibility, animal study, and analytical) and suppliers.
• Independently author engineering reports and presentations as required to document and communicate findings.
• Applies deep knowledge and experiences from across multiple clinical segments to research, develop, and formulate new products/prototypes to develop innovative solutions to satisfy customer needs
• Independently design, execute, compile data, and draw conclusions for complex experimentation.
• Assist with clinical/user needs assessments.
• Assist with intellectual property searches and evaluations.
• Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
• Supports process engineering efforts during process scale-up and manufacturing improvement initiatives.
• Maintain a safe work environment and laboratory notebooks.
• May mentor or supervise less experienced engineers, interns, and co-ops.
• Other duties as reasonably assigned by the management team.

Requirements:

Education

• Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline. Advanced degree preferred.
• 4+ years of medical device industry experience

Experience

• At least 6 years' engineering experience designing or modifying medical devices or implants

Skills

• Demonstrated mastery level knowledge with:
• Tissue engineering, biomaterials, and polymers.
• Design controls.
• Risk management and creating risk analyses.
• Laboratory prototyping.
• Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals, and materials.
• Effective engineering problem solving tools.
• QMS change control.
• Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments. Able to apply techniques and independently interpret results.
• Experience in tissue engineering and biomaterials is a plus.
• Ability to travel as needed (<20%) within the US and globally.
• Exceptional organizational, communication (verbal and written) and interpersonal skills.
• Works independently with general direction and minimal supervision.
• Attention to detail, effective problem solving and decision-making skills.
• Knowledge of MS project software, Outlook, MS Excel, MS Word, MS PowerPoint.

Travel

• 10%

Safety:

• Physical Requirement
• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

• Onsite: Office environment with assigned workstation